This is a non-inferiority randomized study to compare a plastic stent without central lumen (VIADUCT) with self-expandable metal stents for treatment of malignant obstruction of the common bile duct. It is a non-interventional study, a CE mark for the VIADUCT stent exists.

Further study details as provided by Kliniken Ludwigsburg-Bietigheim gGmbH:

Secondary Outcome Measures:

time to stent obstruction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:

76

Study Start Date:

January 2010

Estimated Study Completion Date:

January 2012

Estimated Primary Completion Date:

January 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

patients with malignant obstruction of the common bile duct

Criteria

Inclusion Criteria:

histologically proven malignant biliary stenosis

signs of biliary obstruction

informed consent

Exclusion Criteria:

age under 18

Operations like Roux-Y, biliodigestive Anastomosis, BII

life expectancy less than 3 months

Karnfosky index less than 60%

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063634